# US 8,541,463 B2 · Ketorolac tromethamine compositions for treating or preventing ocular pain > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,541,463 B2 - Document ID: US8541463B2 - Status: Granted - Kind: B2 - Application number: 13/740,426 - Filed: 2013-01-14 - Published: 2013-05-30 - Granted: 2013-09-24 - Earliest claimed: 2003-06-03 - Assignees: Allergan Sales, Inc. - Applicants: Allergan, Inc. - Inventors: Christopher A. Muller; Janet K. Cheetham; Teresa H. Kuan; David F. Power - Web page: https://patentgrep.com/patent/US8541463B2 ## CPC - A61K 31/407: condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine - A61K 9/0048: {Eye, e.g. artificial tears} - A61K 47/02: Inorganic compounds - A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers - A61K 47/183: {Amino acids, e.g. glycine, EDTA or aspartame} - A61K 47/186: {Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide} - A61K 47/24: containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids - A61K 47/34: Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence) - A61P 25/04: Centrally acting analgesics, e.g. opioids - A61P 27/02: Ophthalmic agents - A61P 27/04: Artificial tears; Irrigation solutions - A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract Compositions comprising ketorolac tromethamine at a therapeutically effective concentration of less than 0.5% are disclosed herein. Methods of treating or preventing ocular pain using said compositions are also disclosed herein. ## Claims ### Claim 1 A method of treating ocular pain and burning/stinging in a patient, the method comprising the step of administering at least once daily to an eye of the patient a first composition comprising about 0.4% w/v ketorolac tromethamine, wherein the method reduces ocular pain and burning/stinging and results in less ocular side effects as compared to the at least once daily administration to an eye of a second composition comprising 0.5% w/v ketorolac tromethamine. ### Claim 2 (depends on 1) The method of claim 1, wherein the side effects include at least one side effect from the group consisting of ocular irritation, foreign body sensation or both. ### Claim 3 (depends on 1) The method of claim 1, wherein the method reduces inflammation in the eye of the patient. ### Claim 4 (depends on 1) The method of claim 1, wherein the method comprises the step of administering four times daily to an eye of the patient a first composition comprising about 0.4% w/v ketorolac tromethamine, wherein the method reduces ocular pain and burning/stinging and results in less ocular side effects as compared to the four times daily administration to an eye of a second composition comprising about 0.5% w/v ketorolac tromethamine. ### Claim 5 (depends on 1) The method of claim 1, wherein administration of the first composition results in increased ocular comfort as compared to the administration to the eye of the second composition. ### Claim 6 (depends on 3) The method of claim 3, wherein administration of the first composition results in increased ocular comfort as compared to the administration to the eye of the second composition. ### Claim 7 (depends on 1) The method of claim 1, wherein the first composition is as effective in treating ocular pain as the second composition, despite having a lower concentration of ketorolac tromethamine. ### Claim 8 (depends on 1) The method of claim 1, wherein the side effects include at least one side effect selected from the group consisting of ocular irritation, ocular burning and ocular stinging. ### Claim 9 (depends on 1) The method of claim 1, wherein the administration is by topical instillation. ### Claim 10 (depends on 1) The method of claim 1, wherein the first composition comprises edetate disodium. ### Claim 11 (depends on 1) The method of claim 1, wherein the person is experiencing ocular pain due to corneal refractive surgery. ### Claim 12 (depends on 1) The method of claim 1, wherein the method results in analgesic activity to the patient's eye. ### Claim 13 (depends on 1) The method of claim 1, wherein the method reduces pain and ocular stinging after ophthalmic surgery. ### Claim 14 (depends on 13) The method of claim 13, wherein the surgery is corneal refractive surgery. ### Claim 15 (depends on 1) The method of claim 1, wherein the method reduces ocular burning after ophthalmic surgery. ### Claim 16 (depends on 1) The method of claim 1 wherein the first composition comprises 0.4% ketorolac tromethamine and about 0.006% benzalkonium chloride. ### Claim 17 (depends on 1) The method of claim 1 wherein the first composition comprises 0.4% w/v ketorolac tromethamine, about 0.006% w/v benzalkonium chloride and about 0.015% w/v edetate disodium. ### Claim 18 (depends on 1) The method of claim 1 wherein the first composition comprises 0.4% w/v ketorolac tromethamine, about 0.006% w/v benzalkonium chloride, about 0.015% w/v edetate disodium and about 0.003% w/v octoxynol 40. ### Claim 19 (depends on 1) The method of claim 1 wherein the first composition comprises 0.4% w/v ketorolac tromethamine, about 0.006% w/v benzalkonium chloride, about 0.015% w/v edetate disodium, about 0.003% w/v octoxynol 40 and water. ### Claim 20 (depends on 1) The method of claim 1 wherein the first composition comprises 0.4% w/v ketorolac tromethamine, about 0.006% w/v benzalkonium chloride, about 0.015% w/v edetate disodium, about 0.003% w/v octoxynol 40, water and hydrochloric acid and sodium hydroxide to adjust the pH to about 7.4.